Events

Retiro De Equipo (Recall) de TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Nipro Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-01079-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-30
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01079-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    As part of nipro diagnostics internal manufacturing process blood glucose meters are required to be reconfigured to meet country specific requirements. during the reconfiguration process, the unit of measure was set incorrectly on a small subset of truebalance and truetrack meters supplied in australia. specifically, a miscalibrated meter would use mg/dl instead of mmol/l, which is the standard unit used in australia.This recall was initiated by nipro australia prior to consulting with the tga.
  • Acción
    Nipro is advising users to check the serial number on the back of the meter to identify if their meter is affected. An alternative method for measuring blood glucose levels should be used if you have an affected meter. Affected meters can be returned to Nipro for a replacement unit. For more details, please see http://tga.gov.au/safety/alerts-device-nipro-glucose-meter-131031.htm .

Device

TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems

Manufacturer

Nipro Australia Pty Ltd